Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12617001272381
Ethics application status
Approved
Date submitted
30/08/2017
Date registered
4/09/2017
Date last updated
8/04/2021
Date data sharing statement initially provided
9/01/2019
Date results information initially provided
9/01/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Evaluation of the incidence and type of psychosocial needs in 14-24 year old offspring of women with early or metastatic breast cancer
Query!
Scientific title
Evaluation of the incidence and type of psychosocial needs in 14-24 year old offspring of women with early or metastatic breast cancer
Query!
Secondary ID [1]
292730
0
BCRC116
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Breast Cancer Offspring Study (BCOS)
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Psychosocial needs
304495
0
Query!
Breast cancer
304496
0
Query!
Condition category
Condition code
Mental Health
303832
303832
0
0
Query!
Studies of normal psychology, cognitive function and behaviour
Query!
Cancer
303882
303882
0
0
Query!
Breast
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
False
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Participants sign a consent form to confirm in writing they agree to take part in the trial and provide contact details to the study team. Once received, trial staff will phone participants to obtain demographic information about gender, age, schooling, place of birth, family situation (who they live with), whether they have any important medical conditions and any cancer history of their immediate family. Participants will be emailed a link to an online survey comprised of 2 questionnaires online which they are required to complete within 28 days . We anticipate time to participate and complete all aspects of the trial will take individuals a total of 30-40 minutes.
Query!
Intervention code [1]
298974
0
Not applicable
Query!
Comparator / control treatment
No control group
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
303194
0
To assess the incidence and type of psychosocial needs and distress experienced in 14-24 year-old offspring (males and females) of women with early or metastatic breast cancer.
This is a composite primary outcome. This will be assess using a questionnaire designed specifically for this study.
Query!
Assessment method [1]
303194
0
Query!
Timepoint [1]
303194
0
At completion of the questionnaire
Query!
Secondary outcome [1]
338202
0
Demographic variables in the offspring associated with greater degree and severity of needs experienced.
This outcome will be assessed using a questionnaire designed specifically for this study
Query!
Assessment method [1]
338202
0
Query!
Timepoint [1]
338202
0
At completion of the questionnaire.
Query!
Secondary outcome [2]
338203
0
Characteristics of the breast cancer stage and treatment received by their parent that are associated with a greater degree and severity of needs experienced by the offspring.
This is a composite secondary outcome. This will be assess using a questionnaire designed specifically for this study.
Query!
Assessment method [2]
338203
0
Query!
Timepoint [2]
338203
0
At completion of the questionnaire.
Query!
Secondary outcome [3]
338204
0
Differences in demographics, degree and severity of needs experienced if they are CanTeen members or not.
This is a composite secondary outcome. This will be assess using a questionnaire designed specifically for this study.
Query!
Assessment method [3]
338204
0
Query!
Timepoint [3]
338204
0
At completion of the questionnaire.
Query!
Eligibility
Key inclusion criteria
1. Written informed consent of participants (parental consent also required in subjects under 18 years)
2. Written informed consent of the mother “Consent for Use of Personal Health Information”
3. Male and female aged between 14-24yrs at the time of consent
4. Mother diagnosed with stage I to IV breast cancer
5. Able to read English and understand questions asked
6. Participants may be adopted
7. Resides in Western Australia
8. Offspring whose mother with breast cancer is the sole parent are eligible
9. Mother must be a current patient at the research site
Query!
Minimum age
14
Years
Query!
Query!
Maximum age
24
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
1. No social contact with mother who has breast cancer
2. Any personal history of cancer
3. Psychologically or emotionally unable to answer questionnaire as assessed by mother who has breast cancer
4. Any other immediate family member (i.e. another parent, step parent or sibling) receiving treatment for any cancer or diagnosed with any cancer that is not deemed cured.
Query!
Study design
Purpose
Psychosocial
Query!
Duration
Cross-sectional
Query!
Selection
Defined population
Query!
Timing
Prospective
Query!
Statistical methods / analysis
The OCNI (Offspring Cancer Needs Instrument) 47-item questionnaire and Kessler 10 questionnaire will be utilised to measure offspring needs. Demographic information of the offspring and details of the mother’s disease and treatment will be obtained. The incidence of types and severity of psychosocial needs will be reported as the primary endpoint. Factors including offspring demographics, the patient’s disease stage and treatment received at the time of study will be analysed for which variables are predictive of a higher likelihood of needs experienced in the offspring.
• Consenting offspring will be asked to complete the OCNI and Kessler 10
• Demographic details of offspring will be collected
• Information on patient demographics, disease details, treatment received and breast cancer status will be collated.
Consecutive study participants over a 6-month will be included in the study sample. It is anticipated that up to 100 participants will be recruited. Participants must complete both the OCNI and the Kessler 10 questionnaires to be included in the sample size
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
18/09/2017
Query!
Actual
18/09/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
7/03/2018
Query!
Date of last data collection
Anticipated
Query!
Actual
3/05/2018
Query!
Sample size
Target
100
Query!
Accrual to date
Query!
Final
101
Query!
Recruitment in Australia
Recruitment state(s)
WA
Query!
Funding & Sponsors
Funding source category [1]
297368
0
Charities/Societies/Foundations
Query!
Name [1]
297368
0
Breast Cancer Research Centre-WA
Query!
Address [1]
297368
0
Hollywood Consulting Centre
Suite 407, 4th Floor
91 Monash Avenue
Nedlands WA 6009
Query!
Country [1]
297368
0
Australia
Query!
Primary sponsor type
Charities/Societies/Foundations
Query!
Name
Breast Cancer Research Centre-WA
Query!
Address
Hollywood Consulting Centre
Suite 407, 4th Floor
91 Monash Avenue
Nedlands WA 6009
Query!
Country
Australia
Query!
Secondary sponsor category [1]
296345
0
None
Query!
Name [1]
296345
0
Query!
Address [1]
296345
0
Query!
Country [1]
296345
0
Query!
Other collaborator category [1]
279693
0
Charities/Societies/Foundations
Query!
Name [1]
279693
0
CanTeen
Query!
Address [1]
279693
0
Street address: 75 King St, Newtown, NSW 2042
Postal address: GPO Box 3821 Sydney NSW 2001
Query!
Country [1]
279693
0
Australia
Query!
Other collaborator category [2]
279694
0
Individual
Query!
Name [2]
279694
0
Nichola Forster
Query!
Address [2]
279694
0
Hollywood Private Hospital
Suite 5, Hollywood Specialist Centre
95 Monash Avenue
Nedlands, WA 6009
Query!
Country [2]
279694
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
298472
0
Hollywood Private Hospital Research Ethics Committee
Query!
Ethics committee address [1]
298472
0
Hollywood Private Hospital
Locked Bag 2002, Nedlands Perth WA 6909
Query!
Ethics committee country [1]
298472
0
Australia
Query!
Date submitted for ethics approval [1]
298472
0
20/03/2017
Query!
Approval date [1]
298472
0
16/08/2017
Query!
Ethics approval number [1]
298472
0
Query!
Summary
Brief summary
The aim of this study is to evaluate the incidence and type of psychosocial needs in 14-24 year old offspring of women with early or metastatic breast cancer.
Who is it for?
You may be eligible to join this study if you are aged 14-24 years and have a mother diagnosed with stage I to IV breast cancer.
Study details
Study staff will phone participants to obtain demographic information about gender, age, schooling, place of birth, family situation (who they live with), whether they have any important medical conditions and any cancer history of their immediate family. Participants will be emailed a link to an online survey comprised of 2 questionnaires online which they are required to complete within 28 days. We anticipate time to participate and complete all aspects of the trial will take individuals a total of 30-40 minutes.
Information collected will be analysed with the aim of identifying what the needs and the best types of support that can be provided to help other young people who also have mothers with cancer.
Query!
Trial website
http://bcrc-wa.com.au/our-research/current-trials/
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
77186
0
Prof Arlene Chan
Query!
Address
77186
0
Suite 407, Hollywood Consulting Centre, 91 Monash Avenue, Nedlands WA 6009.
Query!
Country
77186
0
Australia
Query!
Phone
77186
0
+61 8 94814522
Query!
Fax
77186
0
Query!
Email
77186
0
[email protected]
Query!
Contact person for public queries
Name
77187
0
Mrs Karen Shakespeare
Query!
Address
77187
0
Suite 407, Hollywood Consulting Centre, 91 Monash Avenue, Nedlands WA 6009.
Query!
Country
77187
0
Australia
Query!
Phone
77187
0
+61 8 65005555
Query!
Fax
77187
0
Query!
Email
77187
0
[email protected]
Query!
Contact person for scientific queries
Name
77188
0
Prof Arlene Chan
Query!
Address
77188
0
Suite 407, Hollywood Consulting Centre, 91 Monash Avenue, Nedlands WA 6009.
Query!
Country
77188
0
Australia
Query!
Phone
77188
0
+61 8 94814522
Query!
Fax
77188
0
Query!
Email
77188
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Data will only be shared amongst participating investigators as pertains to the study endpoints and specified analyses
Query!
When will data be available (start and end dates)?
At time of data clean and first data analysis and up until time of final publication
Query!
Available to whom?
Participating investigators
Query!
Available for what types of analyses?
Analyses as planned per protocol, or as exploratory analyses based on study’s findings which may serve as rationale for further clinical research evaluation
Query!
How or where can data be obtained?
Data fields from primary study database will be shared as deidentified records in Excel spreadsheet
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Chan A, Lomma C, Chih HJ, et al. Psychosocial con...
[
More Details
]
373532-(Uploaded-19-01-2021-12-52-21)-Journal results publication.pdf
Documents added automatically
No additional documents have been identified.
Download to PDF